Atrial Fibrillation, Cryptogenic Stroke, Embolic Stroke of Undetermined Source, Implantable Cardiac Monitor, Oral Anticoagulation, Secondary Stroke Prevention, Women's Health
Conditions
Keywords
Cerebrovascular Disorder, Cardiovascular Disease, Cardiac arrhythmias, Stroke, Ischemic stroke, Atrial Fibrillation, Sex-differences, Women's Health, Secondary Stroke Prevention, Oral anticoagulation, Embolic stroke
Brief summary
The goal of this observational study is to investigate sex - differences in detection rate of atrial fibrillation after cryptogenic stroke (embolic stroke of unknown cause) - using an implantable cardiac rhythm monitor - and the treatment effects of oral anticoagulation on recurrent stroke, ischemic cardiovascular events, major bleeding risk, disability and mortality. The main questions to answer are: * Is long-term monitoring and detection of atrial fibrillation after stroke of unknown cause in women related to recurrent stroke and disability? * Is long-term monitoring and initiation of oral anticoagulation related to cardiovascular events and intracranial haemorrhages? And in addition increased in women compared to men? * Is long-term rhythm monitoring after stroke with unknown cause related to patient reported outcomes in women?
Detailed description
This is a prospective, observational, study including consecutive patiens with acute cryptogenic stroke /embolic stroke of unknown source (ESUS) or transient ischemic attack (TIA) admitted between 2016 and 2023 at Akershus University Hospital (AUH). As part of the standard investigation at AUH, selected patients are offered an implantable cardiac monitor (ICM) and followed up for detection of atrial fibrillation (AF) by a specialised neurocardiology team. A control group recruited at another hospital during the same period, Haukeland University Hospital (HUS), only comprise women. The primary objectives: * To investigate among women with stroke of unknown cause, the effect of implantable cardiac monitors compared to standard non-invasive approach on AF detection, recurrent stroke, death and disability. * To investigate sex- differences in patients with stroke of unknown cause, the effect of implantable cardiac monitors on AF detection, recurrent stroke, death and disability. Secondary objectives: * To compare the rate of cardiovascular events and intracranial haemorrhages after stroke of unknown cause in women offered implantable cardiac monitors, compared to best standard non-invasive follow up * To investigate the impact of implantable cardiac monitors on the use of oral anticoagulation in women * To investigate self-perceived health and health related quality of life after stroke of unknown cause in women offered implantable loop recorders, compared to women offered best standard non-invasive approach to detect AF
Interventions
None listed
Sponsors
Haukeland University Hospital
The Dam Foundation
The Norwegian Women´s Public Health Association
University of Oslo
University Hospital, Akershus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with cryptogenic stroke or TIA, according to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification and an implantable cardiac rythm monitor (ICM) for the ICM group not the control
Exclusion criteria
* Patients with known or newly detected AF on standard ECG or 24 h Holter ECG. * Patients on oral anticoagulants (OAC) for non-AF indications * Patients with strong contraindications for OAC * Severe cognitive impairment or disability or with a short life expectancy due to comorbidities of less than two years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation deteceted after stroke and transient ischemic attack (TIA) | 30 days and 1 year after index stroke | \>30 seconds of atrial fibrillation detection using implantable cardiac monitor/implantable loop-recorder |
| Recurrent ischemic stroke after 1 and 2 years | 30 days, 1 and 2 years after index stroke | Ischemic stroke/TIA: Clinical diagnosis (TOAST criteria) verified by CT and/or MR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite of stroke and mortality | 30 days, 1 and 2 years after index stroke | Ischemic and heamorragic stroke, (ICD-10 I63 and I61) transient ischemic attack(TIA) (ICD10: G45.9) and mortality |
| Intracranial bleeding | 30 days, 1 and 2 years after index stroke | Symptomatic intracranial heamorrage (stroke) (ICD-10: I61) |
| Safety outcome | 1 and 2 years after index stroke | Hospitalized for gastrointestinal bleeding (ICD 10 K92) and/or intracranial bleeding (I61) |
| Ischemic cardiac events | 1 and 2 years | Hospitaized for ischemic cardiac events (ICD10 20-25) |
| Functional outcome 3 months post-stroke | 3 months after index stroke | Functional outcome 3 months post-stroke using modified Rankin Scale (mRS) from the national stroke registry |
| Patient Reported Outcome Measureres | 3 months after index stroke | Self-perceived health and health related quality of life by using the EuroQol scale (EQ-5D-5L) |
| Oral anticoagulation | 1 and 2 years | Use of oral anticoagulation |
Countries
Norway
Outcome results
None listed